Role Description

The Senior Director of Quality Excellence (Systems & Technology) is a strategic quality leader responsible for shaping, executing, and continuously advancing the enterprise Quality Management System (QMS) and Quality systems operating model across Praxis Precision Medicines. This individual provides vision and direction for all Quality Systems functions including:

• Veeva QMS governance
• Document control
• GxP training administration
• Validation and inspection readiness
• Supplier oversight for Quality Systems and GxP computerized system providers

This role ensures a compliant, efficient, and scalable quality infrastructure that supports the company’s global clinical, manufacturing, and commercial operations.

The Senior Director serves as the organization’s subject matter expert on GxP system compliance, regulatory readiness, and quality systems excellence. This role is accountable for:

• Strategy, oversight, and continuous improvement of Praxis’s QMS and validation programs
• Ensuring all GxP systems are fit for intended use and maintained in a controlled state
• Aligning with current industry expectations (e.g., CSA concepts and GAMP 5)

Partnering closely with senior leadership across Quality, Clinical, Technical Operations, and IT, the Senior Director drives a culture of proactive quality, operational discipline, and continuous improvement.

Primary Responsibilities

• Lead the strategy, governance, and continuous improvement of Praxis’s enterprise QMS to ensure compliance with global GxP regulations.
• Serve as the process owner for QMS elements including document control, deviation/CAPA management, change control, training, and risk management.
• Provide leadership and oversight for computerized lifecycle controls (CSV/CSA) for GxP computerized systems.
• Partner with IT, Clinical Operations, Technical Operations, and Commercial teams to establish risk-based lifecycle standards.
• Evaluate and qualify vendors, CROs, and CMOs supporting Praxis systems.
• Maintain oversight of electronic systems, including Veeva QMS.
• Lead the global GxP training administration program.
• Establish and oversee QMS governance mechanisms.
• Ensure ongoing inspection readiness across all GxP functions.
• Monitor evolving regulatory expectations and implement timely updates.
• Define, monitor, and report key QMS and validation metrics.
• Lead, mentor, and develop a high-performing team of QMS and validation professionals.
• Represent Quality leadership in enterprise governance and initiatives.
• Drive sustained inspection readiness and execution support.

Qualifications

• BS/BA in a relevant scientific discipline, or ASQ or equivalent professional certification; equivalent experience considered.
• Minimum 15 years of progressive experience in the pharmaceutical or biotechnology industry, with direct Quality Systems and Quality Assurance experience; at least five years in a leadership role.
• Demonstrated expertise in developing, implementing, and managing enterprise QMS across clinical, manufacturing, and commercial functions.
• Proven success governing QMS processes such as document control, training, deviation/CAPA, change management, and risk management.
• Hands-on experience validating GxP and enterprise systems.
• Demonstrated leadership experience supporting both clinical-stage and commercial operations environments.
• Documented history supporting regulatory inspections and partner audits.
• Strong working knowledge of FDA, EMA, and global GxP regulations.
• Demonstrated ability to analyze and optimize quality processes.
• Strategic, solutions-driven quality leader with excellent collaboration, communication, and influencing skills.
• Proficient in Veeva Vault applications, DocuSign, and SharePoint.

Requirements

• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.
• Comfort with screen work, basic hand coordination, and focus.
• Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Benefits

• 99% of the premium paid for medical, dental, and vision plans.
• Company-paid life insurance, AD&D, disability benefits, and voluntary plans.
• 401(k) contributions matched dollar-for-dollar up to 6%.
• Long-term stock incentives and ESPP.
• Discretionary quarterly bonus.
• Flexible wellness benefit.
• Generous PTO, paid holidays, and company-wide shutdowns.

Company Description

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Our core values of Trust, Ownership, Curiosity, and Results are foundational to every aspect of our business.

At Praxis, we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion.